Clinical trials: Revision Total Shoulder Arthroplasty
Osteoarthritis Shoulder, Rheumatoid Arthritis
TESS V3 Modular Total Shoulder System PMCF
This is a multicenter, retrospective and prospective, non-controlled post market surveillance study. The objectives of this study are to confirm safety, performance and clinical benefits of the T.E.S.S.® Version 3 Anatomic and…
- Conditions
- Osteoarthritis Shoulder, Rheumatoid Arthritis, Rheumatoid Arthritis Shoulder, Avascular Necrosis
- Trial name
- NCT05002959
- Testing
- Anatomic TESS V3, Reverse TESS V3
- Where
- 2 sites in France
- Volunteers
- 67 people
- Sponsor
- Zimmer Biomet
Rheumatoid Arthritis, Osteoarthritis Shoulder
Tornier HRS (Humeral Reconstruction System) Study (REVIVE)
This is an international, single arm, multicenter, prospective follow-up, non-significant risk, Post-Market Clinical Follow-up (PMCF) study.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis Shoulder, Fractures Humerus, Avascular Necrosis
- Trial name
- REVIVE (NCT05500066)
- Testing
- Tornier HRS (HUMERAL RECONSTRUCTION SYSTEM) shoulder system
- Where
- 4 sites in United States
- Volunteers
- 110 people
- Sponsor
- Stryker Trauma and Extremities
Avascular Necrosis, Revision Surgery
Anatomical Shoulder Domelock System Study
The objectives of this study are to confirm safety and performance of the Anatomical Shoulder Domelock System when used in hemi or total shoulder arthroplasty by analysis of standard scoring systems, radiographs and adverse event…
- Conditions
- Avascular Necrosis, Revision Surgery, Conditions Consequent to Earlier Operations, Arthritis, Rheumatoid
- Trial name
- NCT03312465
- Testing
- AS Domelock System
- Where
- 6 sites in Belgium, Germany and 2 more
- Volunteers
- 73 people
- Sponsor
- Zimmer Biomet
Shoulder Pain, Shoulder Injuries
MDR - Comprehensive Primary/Micro Stem & Versa-Dial Ti Humeral Head
The objective of this retrospective/prospective enrollment and prospective follow-up consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Primary Micro Stem…
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Disease
- Trial name
- NCT04003311
- Testing
- Comprehensive Primary Micro Stem, Comprehensive Anatomic Versa-Dial Titanium Humeral Head
- Where
- 4 sites in United States
- Volunteers
- 146 people
- Sponsor
- Zimmer Biomet
Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency
Long-term Clinical Effectiveness of the Delta Xtend Reverse Total Shoulder
This post-marketing study is designed to collect data relating to the use of the Delta Xtend™ Total Shoulder Replacement System in shoulder with rotator cuff deficiencies.
- Conditions
- Cuff Tear Arthropathy, Osteoarthritis With Cuff Deficiency, Rheumatoid Arthritis, Post Traumatic Injury to Shoulder
- Trial name
- NCT00737087
- Testing
- Delta Xtend Reverse Total Shoulder
- Where
- 5 sites in Belgium, France and 1 more
- Volunteers
- 144 people
- Sponsor
- DePuy International
Periprosthetic Infection, Oral Antibiotics
Prospective Evaluation of Oral Antibiotics for Treatment of Shoulder PJI
Cutibacterium acnes (C. acnes) is an anaerobic aerotolerant bacteria commonly isolated during revision shoulder surgery. It is increasingly recognized as a pathogen, mainly in implant-related infections.
- Conditions
- Periprosthetic Infection, Oral Antibiotics, Revision Total Shoulder Arthroplasty
- Trial name
- NCT04636125
- Testing
- Doxycycline 100 MG Oral Tablet
- Where
- United States
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Rothman Institute Orthopaedics
Shoulder Pain, Shoulder Injuries
MDR - Comprehensive Reverse/Versa Dial Ti Glenosphere
The objective of this retrospective/prospective consecutives series PMCF study is to collect data confirming safety, performance and clinical benefits of the Comprehensive Versa-Dial Reverse Ti Glenosphere when used for primary…
- Conditions
- Shoulder Pain, Shoulder Injuries, Shoulder Fractures, Shoulder Arthritis
- Trial name
- NCT04003272
- Testing
- Comprehensive Reverse Versa-Dial Titanium Glenosphere
- Where
- 2 sites in United States
- Volunteers
- 59 people
- Sponsor
- Zimmer Biomet
Osteoarthritis of the Shoulder, Avascular Necrosis
Database Retrieval for the Comprehensive Shoulder
This study is a retrieval of database information regarding survivorship of the Comprehensive Shoulder System family of products.
- Conditions
- Osteoarthritis of the Shoulder, Avascular Necrosis, Rheumatoid Arthritis, Prior Failed Revision
- Trial name
- NCT03409718
- Testing
- Biomet Comprehensive Shoulder System
- Where
- United States
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Arthropathy Shoulder
TXA in Revision Total Shoulder Arthroplasty
This is a phase IV, randomized, single-blind, single-center study comparing calculated total blood loss, surgical drain output and hematoma formation in patients who receive 2 doses of Tranexamic Acid (TXA) versus control group…
- Trial name
- NCT04650698
- Testing
- Tranexamic acid (TXA) injection
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- NYU Langone Health
Osteoarthritis, Avascular Necrosis
Post-market Surveillance Study With the HYPERION Hip Endoprosthesis System in Defect Reconstruction
The study is a multi-center, prospective, non-controlled, consecutive cohort post market surveillance study. The objective of this study is to obtain survival and clinical outcome data on the Hyperion® system in primary and…
- Conditions
- Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis, Functional Deformities
- Trial name
- NCT03382665
- Where
- 3 sites in Germany
- Volunteers
- 70 people
- Sponsor
- Zimmer Biomet
Osteoarthritis, Rheumatoid Arthritis
Outcomes Study of the Trabecular Metal (TM) Reverse Shoulder System
The objectives of this study are to obtain survival and outcome data on the Trabecular Metal Reverse Shoulder System when used in primary or revision reverse total shoulder arthroplasty.
- Conditions
- Osteoarthritis, Rheumatoid Arthritis, Post-traumatic Arthritis, Ununited Humeral Head Fracture
- Trial name
- NCT01480440
- Testing
- Trabecular Metal Reverse Shoulder System
- Where
- 5 sites in United States, United Kingdom
- Volunteers
- 200 people
- Sponsor
- Zimmer Biomet
Osteoarthritis of the Shoulder
TITAN™ Reverse Shoulder System
The Integra® TITAN™ Reverse Shoulder System (TRS) is a semi-constrained total shoulder construct. When used under the conditions and purposes intended the TRS will relieve pain and restore some functional joint motion to the…
- Trial name
- NCT02204228
- Testing
- TITAN™ Reverse Shoulder System (TRS)
- Where
- 10 sites in United States, France and 2 more
- Volunteers
- 151 people
- Sponsor
- Smith & Nephew, Inc.